Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001300
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2000-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized study All patients must be randomized to treatment on Arms I and II within 3 months of definitive surgery on Regimen A
Regimen A Surgery followed as indicated by Radiotherapy Amputation or limb-sparing resection followed by involved-field irradiation using megavoltage equipment with or without electron boost
Arm I 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation and Urothelial Protection Doxorubicin DOX NSC-123127 Ifosfamide IFF NSC-109724 with Granulocyte Colony Stimulating Factor Amgen G-CSF
NSC-614629 and Mesna NSC-113891
Arm II Observation No adjuvant chemotherapy
Regimen A Surgery followed as indicated by Radiotherapy Amputation or limb-sparing resection followed by involved-field irradiation using megavoltage equipment with or without electron boost
Arm I 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation and Urothelial Protection Doxorubicin DOX NSC-123127 Ifosfamide IFF NSC-109724 with Granulocyte Colony Stimulating Factor Amgen G-CSF
NSC-614629 and Mesna NSC-113891
Arm II Observation No adjuvant chemotherapy
Detailed Description:
Patients with primary high-grade soft tissue sarcoma of the extremities will undergo treatment of their primary tumor with either amputation or limb-sparing surgery and radiotherapy and then be randomized to either observation or adjuvant treatment with doxorubicin and ifosfamide with mesna with G-CSF for five cycles beginning post-operatively Local recurrence disease-free survival and overall survival will be evaluated in this randomized two-arm trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 92-C-0210 | None | None | None |